Accord Healthcare, Inc. recalls Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured…
Presence of Particulate Matter: Particulate matter identified as fiber.
Read the official notice →- Date
- 2023-07-19
- Country
- United States
- Brand
- Accord Healthcare
- Product
- Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured…
- Classification
- Class II
- Units
- Nationwide within the United States
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Accord Healthcare recalls
- 2024-11-06
USACCORD HEALTHCARE, INC. recalls Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15,…
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- 2024-10-23
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ACCORD HEALTHCARE, INC. recalls Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare…
Failed Impurities/Degradation Specifications.
- 2024-07-10
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Accord Healthcare, Inc. recalls Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc.,…
Subpotent drug: out of specification results
- 2023-04-12
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Accord Healthcare, Inc. recalls Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx…
Sub-potent drug: assay test result below specifications at 9-month timepoint.
- 2023-03-08
- US
Accord Healthcare, Inc. recalls Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured…
CGMP Deviations: recalling drug products following an FDA inspection.
- 2023-02-01
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Accord Healthcare, Inc. recalls Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by:…
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Other drugs & medical recalls in the United States
- 2023-07-19
- US
Cipla USA, Inc. recalls Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured…
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
- US
Global Pharma Healthcare Private Limited recalls Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle,…
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
FDA · DrugGlobal Pharma Healthcare Private LimitedProduct was distributed to two distributors who further distributed Nationwide…Official notice → - US
Global Pharma Healthcare Private Limited recalls Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle,…
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
FDA · DrugGlobal Pharma Healthcare Private LimitedProduct was distributed to two distributors who further distributed Nationwide…Official notice → - US
B. Braun Medical Inc. recalls 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC…
Lack of assurance of sterility: bags have the potential to leak.
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Tenn South Distillery LLC dba Big Machine Distillery recalls Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution,…
CGMP Deviation: impurities exceed allowable limits.
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512,…
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing